Imported Fire Ant; Approved Treatments

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 301

[Docket No. 96-063-3]

Imported Fire Ant; Approved Treatments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the imported fire ant regulations to

lengthen the certification period for containerized nursery stock

treated with a 10 parts per million dosage of the insecticide

tefluthrin in its granular formulation and to remove the 15 parts per

million dosage rate for granular tefluthrin. Research has demonstrated

that a 10 parts per million dosage of granular tefluthrin is

efficacious for 18 months, which is 12 months longer than the current

certification period for that dosage and 6 months longer than the

current certification period for a 15 parts per million dosage.

Lengthening the certification period for the 10 parts per million

dosage and removing the 15 parts per million dosage would reduce the

amount of insecticide used, which would reduce the costs incurred by

persons moving containerized nursery stock interstate from areas

quarantined for the imported fire ant.

DATES: Consideration will be given only to comments received on or

before March 17, 1997.

ADDRESSES: Please send an original and three copies of your comments to

Docket No. 96-063-3, Regulatory Analysis and Development, PPD, APHIS,

Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please

state that your comments refer to Docket No. 96-063-3. Comments

received may be inspected at USDA, room 1141, South Building, 14th

Street and Independence Avenue SW., Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday, except holidays. Persons wishing to

inspect comments are requested to call ahead on (202) 690-2817 to

facilitate entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Mr. Ronald P. Milberg, Operations

Officer, Program Support, PPQ, APHIS, 4700 River Road Unit 134,

Riverdale, MD 20737-1236, (301) 734-5255; or E-mail:

[email protected].

SUPPLEMENTARY INFORMATION:

Background

Imported fire ants, Solenopsis invicta Buren and Solenopsis

richteri Forel, are aggressive, stinging insects that, in large

numbers, can seriously injure or even kill livestock, pets, and humans.

The imported fire ant feeds on crops and builds large, hard mounds that

damage farm and field machinery.

The regulations in ``Subpart--Imported Fire Ant'' (7 CFR 301.81

through 301.81-10, referred to below as the regulations) quarantine

infested States or infested areas within States and impose restrictions

on the interstate movement of certain regulated articles from those

quarantined States or areas for the purpose of preventing the

artificial spread of the imported fire ant.

Sections 301.81-4 and 301.81-5 of the regulations provide, among

other things, that regulated articles requiring treatment prior to

interstate movement must be treated in accordance with the methods and

procedures prescribed in the appendix to the subpart, which sets forth

the treatment provisions of the ``Imported Fire Ant Program Manual.''

Currently, the appendix offers three dosage rate/certification

period options for granular tefluthrin: 0 to 6 months for a 10 parts

per million (ppm) dosage, 0 to 12 months for a 15 ppm dosage, and a

continuous certification period for a 25 ppm dosage.

Tests conducted by the Animal and Plant Health Inspection Service

(APHIS) at its Imported Fire Ant Methods Development Station (IFAMDS)

in Gulfport, MS, have demonstrated that granular tefluthrin

incorporated at a dosage rate of 10 ppm into soil or potting media for

containerized nursery stock is efficacious for 18 months. This is 12

months longer than the current certification period for a 10 ppm dosage

and 6 months longer than the current certification period for a 15 ppm

dosage. Based on that efficacy data, we have determined that

containerized nursery stock could be certified for interstate movement

for 18 months after treatment with granular tefluthrin at a dosage rate

of 10 ppm.

Therefore, we are proposing to amend the appendix to the

regulations by increasing the certification period for the 10 ppm

dosage of granular tefluthrin from 0-6 months to 0-18 months. In light

of that longer certification period for the lower 10 ppm dosage, the 15

ppm dosage, which has a certification period of 0 to 12 months, would

no longer be necessary and would be removed. The dosage rate of 25 ppm

would be required for certification of containerized nursery stock for

interstate movement from quarantined areas for more than 18 months.

[[Page 4665]]

Previous Direct Final Rule

On October 15, 1996, we published in the Federal Register (61 FR

53601-53603, Docket No. 96-063-1) a direct final rule to amend the

regulations in the same way as proposed in this document, i.e., to

lengthen the certification period for 10 ppm dosage of granular

tefluthrin and remove the 15 ppm dosage rate. In response to that

direct final rule, we received two adverse comments. Therefore, in

accordance with our published policy on direct final rules, we withdrew

the direct final rule prior to its effective date in a document

published in the Federal Register on December 13, 1996 (61 FR 65459,

Docket No. 96-063-2).

Both of the adverse comments we received stated that the research

conducted at IFAMDS did not demonstrate that a 10 ppm dosage of

tefluthrin will provide 18 months of control. The commenters focused on

the regression equation used to chart the data generated by that

research. While they acknowledged that the regression equation did

indeed show that a 10 ppm dosage of tefluthrin would provide 18 months

of control, they questioned the validity of the equation itself.

The tefluthrin trials conducted by IFAMDS covered 46 individual

tests conducted over 15 different projects using a 1.5 percent granular

formulation of the insecticide incorporated with nursery potting media.

The dosage rates tested in those projects ranged from 2.5 ppm to 86.3

ppm. Those dosage rates were shown to provide residual activity--i.e.,

fire ant control--for periods ranging from greater than 1 month for the

2.5 ppm dosage to 43 months for the 86.3 ppm dosage. When those

research results were charted and the generated regression equation of

Y = 16.29 + 0.19X was applied, the data indicated that a 10 ppm dosage

of tefluthrin would provide greater than 18 months of control. Based on

that research, APHIS personnel at IFAMDS recommended that the

regulations be amended to reflect a 0-18 month certification period for

a 10 ppm dosage of tefluthrin and a continuous certification period for

a 25 ppm dosage, which is what we attempted to do in the October 1996

direct final rule that was withdrawn due to our receipt of adverse

comments.

The adverse comments we received were based on two arguments. The

first argument is that the regression equation used by APHIS to support

an 18-month certification period for a 10 ppm dosage of tefluthrin also

predicts that a 0 ppm dosage--i.e., no insecticidal treatment at all--

would provide greater than 16 months of control. We believe that this

argument is a misinterpretation of the facts in that the commenters are

merely pointing to the chart used to represent the results of the

tefluthrin trials and noting that the regression line to the data

points, when extended to 0 on the X axis (dose rate/ppm), intersects

the Y axis (months residual activity) at 16. That line is unsupported

by data points at 0 on the X axis and cannot reasonably be represented

as unequivocally supporting a 16-month certification period for a 0 ppm

dosage. We believe that such an interpretation is an extreme inference

that misrepresents the function of regression equation methodology and

mischaracterizes the nature of the conclusions that can be logically

drawn from the research conducted by IFAMDS.

The second argument employed in the adverse comments is that the

regression equation is inappropriate because it fails to consider that

the equation was generated using the least squares technique to fit the

best line to the data points. That means, one comment stated, that

roughly half of the data points will fall above the regression line and

half will fall below. Thus, the comment continued, the data can be

interpreted as showing tefluthrin applied at 10 ppm would fail to

provide 18 months of control 50 percent of the time and at 25 ppm would

fail to provide 18 months of control 33 percent of the time. We

continue to believe that the methodology used is valid and appropriate

and provides a rational basis for our proposal to amend the regulations

to reflect a 0-18 month certification period for a 10 ppm dosage of

tefluthrin and a continuous certification period for a 25 ppm dosage.

The methodology used in the tefluthrin trials has been used by IFAMDS

in conducting trials for the other insecticidal chemicals and

formulations that are currently approved for use--and are being used to

good effect--in the imported fire ant program.

A recent example of the application of this methodology to the

imported fire ant program was the approval of reduced rates of granular

bifenthrin for incorporation in containerized nursery stock. (Those

reduced rates were added to the regulations by a direct final rule

published in the Federal Register of October 28, 1993 [58 FR 57952-

57955, Docket No. 93-082-1].) The regression equation used for

bifenthrin in that case could be interpreted as predicting that a 0 ppm

dosage of granular bifenthrin would provide approximately 13 months of

control; that a 15 ppm dosage would fail to provide 24 months of

control 50 percent of the time; and that a 25 ppm dosage would fail to

provide 24 months of control 20 percent of the time. Granular

bifenthrin has been used as an efficacious and dependable component of

the imported fire ant program since that direct final rule became

effective on December 27, 1993; the research conducted by IFAMDS leads

us to fully expect that tefluthrin applied at the rates proposed in

this document would be similarly effective in preventing the spread of

the imported fire ant.

Therefore, having considered the adverse comments received in

response to the previous direct final rule, we still believe that

efficacy data generated by IFAMDS and the methodology used to develop

the data provide an appropriate scientific basis for our proposed

lengthening of the certification period for a 10 ppm dosage of granular

tefluthrin.

Executive Order 12866 and Regulatory Flexibility Act

This proposed rule has been reviewed under Executive Order 12866.

For this action, the Office of Management and Budget has waived its

review process required by Executive Order 12866.

This proposed rule would amend the regulations by lengthening the

certification period for containerized nursery stock treated with a 10

ppm dosage of granular tefluthrin and by removing the 15 ppm dosage

rate for granular tefluthrin. Lengthening the certification period for

the 10 ppm dosage and removing the 15 ppm dosage would reduce the

amount of insecticide used, which would reduce the costs incurred by

persons moving containerized nursery stock interstate from areas

quarantined for the imported fire ant.

The number of current users of granular tefluthrin--and the number

of potential new users that could result from this proposed rule

change--is not known, but most are assumed to be small entities

(wholesalers of nursery stock having fewer than 100 employees, and

retail nurseries having less than $5 million in annual revenue).

Several thousand nursery wholesalers and retailers have signed

compliance agreements under the imported fire ant regulations, but not

all of these are necessarily shipping restricted products requiring the

application of granular tefluthrin or alternative chemicals out of the

regulated areas. Moreover, most nurseries under compliance agreements

currently use treatments other than tefluthrin. Therefore, it is

difficult to estimate how many small entities would be affected by this

proposed rule

[[Page 4666]]

change, but they may number in the hundreds.

Costs for most users of granular tefluthrin would be reduced

because of the increased period of certification. Under the current

regulations, a dose rate of 15 ppm is required for a certification

period up to 12 months and a dose rate of 25 ppm is required for a

certification period greater than 12 months. Thus, a cost savings of

from 33 to 60 percent would be realized by purchasers of granular

tefluthrin who ship their products out of the restricted areas between

12 and 18 months after treatment. The current retail price of granular

tefluthrin is about $4.00 per pound, but prices can vary considerably

depending upon whether or not it is purchased in bulk. A 33 to 60

percent cost savings realized by applying tefluthrin at a 10 ppm dose

rate rather than a 15 or 25 ppm dose rate could mean a savings of about

$1.33 to $2.40 in the application of one pound of granular tefluthrin.

We do not anticipate that there would be a significant economic

impact on small entities that distribute agricultural chemicals.

Distributors of agricultural chemicals are diversified businesses that

sell a wide variety of chemicals, fertilizers, and other farm and

nursery supplies. We also do not expect any significant economic impact

on any other small entities.

Under these circumstances, the Administrator of the Animal and

Plant Health Inspection Service has determined that this action would

not have a significant economic impact on a substantial number of small

entities.

Executive Order 12372

This program/activity is listed in the Catalog of Federal Domestic

Assistance under No. 10.025 and is subject to Executive Order 12372,

which requires intergovernmental consultation with State and local

officials. (See 7 CFR part 3015, subpart V.)

Executive Order 12988

This proposed rule has been reviewed under Executive Order 12988,

Civil Justice Reform. If this proposed rule is adopted: (1) All State

and local laws and regulations that are inconsistent with this rule

will be preempted; (2) no retroactive effect will be given to this

rule; and (3) administrative proceedings will not be required before

parties may file suit in court challenging this rule.

Paperwork Reduction Act

This proposed rule contains no information collection or

recordkeeping requirements under the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.).

List of Subjects in 7 CFR Part 301

Agricultural commodities, Plant diseases and pests, Quarantine,

Reporting and recordkeeping requirements, Transportation.

Accordingly, 7 CFR part 301 would be amended as follows:

PART 301--DOMESTIC QUARANTINE NOTICES

1. The authority citation for part 301 would continue to read as

follows:

Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, and

164-167; 7 CFR 2.22, 2.80, and 371.2(c).

2. In part 301, Subpart--Imported Fire Ant, in the appendix to the

subpart, paragraph III.C.3.c. would be amended by revising the dosage

table to read as follows:

Subpart--Imported Fire Ant

* * * * *

Appendix to Subpart ``Imported Fire Ant''--Portion of ``Imported Fire

Ant Program Manual'' 8

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\8\ A copy of the entire ``Imported Fire Ant Program Manual''

may be obtained from the Animal and Plant Health Inspection Service,

Plant Protection and Quarantine, Domestic and Emergency Operations,

4700 River Road Unit 134, Riverdale, MD 20737-1236.

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III. Regulatory Procedures

* * * * *

C. Approved Treatments.

* * * * *

3. Plants--Balled or in Containers

* * * * *

c. Tefluthrin: Granular Formulation.

* * * * *

Dosage: * * *

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Granular tefluthrin dosage (parts per Certification period (months

million) after treatment)

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10 ppm.................................... 0-18 months.

25 ppm.................................... Continuous.

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* * * * *

Done in Washington, DC, this 27th day of January 1997.

Terry L. Medley,

Administrator, Animal and Plant Health Inspection Service.

[FR Doc. 97-2402 Filed 1-30-97; 8:45 am]

BILLING CODE 3410-34-P